NCT05726630 (LIBERIUS) is a Phase 3 clinical trial of Divozilimab in Systemic Scleroderma, sponsored by Biocad.

Who is sponsoring NCT05726630?

NCT05726630 is sponsored by Biocad.

What drugs are being tested in NCT05726630?

Interventions in NCT05726630: Divozilimab, Placebo.

What condition does NCT05726630 study?

NCT05726630 studies Systemic Scleroderma.

Is NCT05726630 still recruiting?

NCT05726630 is currently active, enrolled. Last updated 13 June 2025.

Last reviewed 2025-06-13 · How we verify

NCT05726630: LIBERIUS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study of Divozilimab in Patients With Systemic Scleroderma

Active, enrolled Phase 3 Last updated 13 June 2025

What this trial tests

Phase 3 trial testing Divozilimab in Systemic Scleroderma in 152 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 December 2022

Primary endpoint
1 October 2024

1 February 2027

Quick facts

Lead sponsor	Biocad
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	152
Start date	26 December 2022
Primary completion	1 October 2024
Estimated completion	1 February 2027
Sites	3 locations across Russia

Drugs / interventions tested

Divozilimab — full drug profile →
Placebo

Conditions studied

Systemic Scleroderma — all drugs for Systemic Scleroderma →

Sponsor

Biocad — full company profile →

Who can join

18 and older, any sex, with Systemic Scleroderma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects will be randomized to divozilimab or placebo group.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2024.
Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450
Clinical, mechanistic, and therapeutic landscape of cutaneous fibrosis.
Li DJ, Berry CE, Wan DC, Longaker MT. · · 2024 · cited 14× · PMID 39321265 · DOI 10.1126/scitranslmed.adn7871
Case-Based Immunology: B Cells and Systemic Sclerosis Interstitial Lung Disease.
Goldman N, Ong V, Denton CP. · · 2026 · PMID 40685839 · DOI 10.1002/art.43326

Verify or expand the search:

Other trials of Divozilimab

Trials testing the same drug.

NCT07136389 — Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus · Phase 1 · recruiting
NCT06987851 — An Extension Clinical Study of the Efficacy and Safety of BCD-132 in Patients With Multiple Sclerosis Who Previously Rec · Phase 3 · completed

Other recruiting trials for Systemic Scleroderma

Currently open trials in the same condition.

NCT06056921 — Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease · Phase 1 · recruiting
NCT04380831 — TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis · EARLY_PHASE1 · recruiting
NCT03816345 — Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NI · Phase 1 · recruiting

Other Biocad trials

Trials by the same sponsor.

NCT07136389 — Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus · Phase 1 · recruiting
NCT05974969 — A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subject · Phase 1 · completed
NCT05802225 — Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer · Phase 3 · active not recruiting
NCT05738993 — A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single I · Phase 1 · unknown
NCT05986331 — Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05726630 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biocad
Last refreshed: 13 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05726630.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing